MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE FOLEY CATHETER

Model Number 165816

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that when the drape was pulled off of the tray, the catheter fell out.Complainant reported that the balloon was deflated and would not hold air.No pieces of the balloon were missing and no medical intervention was required.

Manufacturer Narrative

The reported event was unconfirmed.Received 1 used foley catheter with meter bag attached with the original packaging for evaluation.Per visual inspection no obvious defects were found.No manufacturing defects were observed.Per the functional evaluation, the catheter balloon was inflated with 13 cc of air using a syringe and it was not deflated.After that the catheter balloon was inflated with 10ml of a mix of tap water and blue methylene using a syringe.It was left for 30 minutes resting on a flat surface and no deflation was found.The catheter was then handled at the bifurcation area and no deflation was found.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "recommended inflation capacities: 3cc balloon: use 5ml sterile water.5cc balloon: use 10ml sterile water.30cc balloon: use 35ml sterile water.Do not exceed recommended capacities.Visually inspect the product for any imperfections or surface deterioration prior to use." 1149, 2199: "nl".

Event Description

It was reported that when the drape was pulled off of the tray, the catheter fell out.Complainant reported that the balloon was deflated and would not hold air.No pieces of the balloon were missing and no medical intervention was required.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7291768
• MDR Text Key: 101006834
• Report Number: 1018233-2018-00514
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Device Lot Number: NGBW4205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 03/27/2018
• Supplement Dates FDA Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1